Investigation of the effect and comparison of two high-power laser treatment protocols for the improvement of clinical symptoms in patients with painful points in the upper trapezius muscle: a randomized clinical trial
This study will be conducted in Amin Hospital of Isfahan and it is triple -blind. After selecting the samples, the participants in the study, the researcher and the analyst, are not aware of the allocation method, and the treatment is performed by the clinical caregiver who is aware of the allocation method, and the data collection is also done by them.
Settings and conduct
This study will be conducted in Amin Hospital of Isfahan and it is triple -Blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age more than 18 years, Visual analog scale greater than 5 points, Duration of pain more than a month, Patient satisfaction to participate in the study.
Exclusion Criteria: A history of cervical spine fracture and spine-related problems, Neck surgery, myelopathy or radiculopathy of the neck, Patients with perceptual disorders and pain diagnosis, Patients with myopathy and polyneuropathy, Mental illnesses or cognitive disorders, Receiving narcotics and coronet orally or intravenously, pregnancy and Blood clotting problem
Intervention groups
Group A: In addition to standard and routine treatment. He receives 4 sessions (two sessions per week) of high-power laser (wavelength 910 nm and power of one watt as a pulse and DUTY CYCLE 80% and frequency 60 kHz).
group B: In addition to standard and routine treatment. He receives 4 sessions (two sessions per week) of high power laser (wavelength 1064 nm and power of one watt as a pulse and DUTY CYCLE 80% and frequency 60 kHz).
Group C: Like other groups, they receive standard and routine treatment, but for the purpose of checking the real or psychological effect of the laser, the laser is turned off and without wavelength for them is placed.
Main outcome variables
Reducing pain and disability in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230324057771N1
Registration date:2023-04-24, 1402/02/04
Registration timing:prospective
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
Amin Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 5780
Email address
aminmokhtari111273@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect and comparison of two high-power laser treatment protocols for the improvement of clinical symptoms in patients with painful points in the upper trapezius muscle: a randomized clinical trial
Public title
comparison of two high-power in the upper trapezius muscle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Visual analog scale greater than 5 points
Duration of pain more than a month
Patient satisfaction to participate in the study
Exclusion criteria:
A history of cervical spine fracture and spine-related problems
Neck surgery, myelopathy or radiculopathy of the neck
Patients with perceptual disorders and pain diagnosis
Patients with myopathy and polyneuropathy
Mental illnesses or cognitive disorders
Receiving narcotics and coronet orally or intravenously
pregnancy
Blood clotting problem
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
With the easy sampling method, the referring people who are eligible to enter the study are randomly divided into three intervention, control and control groups. In this study, the classification of people is done in the form of three permutation block method. In this method, A represents the person who receives the intervention, B represents the person who is in the control group, and c represents the person in the control group. By considering the block of three, permutations are determined. Then, using the table of random numbers, we randomly select a starting point and then consider 26 numbers in rows or columns. Finally, by selecting 26 numbers from the table, the total allocation of 78 people will be divided into three groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After selecting the samples, the participants in the study, the researcher and the analyst are not informed about the allocation method and the treatment is done by the clinical caregiver who is aware of the treatment method and the data collection is also done by them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hazarjarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.MUI.MED.REC.1401.420
Health conditions studied
1
Description of health condition studied
pain in the upper trapezius muscle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain reduction in the patient
Timepoint
before the treatment, immediately after the treatment, one month and three months after the treatment in each of the three groups
Method of measurement
VAS pain scale
2
Description
Reducing disability in the patient
Timepoint
before the treatment, immediately after the treatment, one month and three months after the treatment in each of the three groups
Method of measurement
Shoulder Pain and Disability Index (SPADI) scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to standard and routine treatment. He receives 4 sessions (two sessions per week) of high power laser (wavelength 910 nm and power of one watt as pulse and 80% duty cycle and frequency 60 kHz).
Category
Treatment - Devices
2
Description
Intervention group: Intervention group: In addition to standard and routine treatment. He receives 4 sessions (two sessions per week) of high power laser (wavelength 1064 nm and power of one watt as a pulse and 80% DUTY CYCLE and frequency 60 kHz).
Category
Treatment - Devices
3
Description
Control group: Like other groups, they receive standard and routine treatment including corrective exercises and POSTURE training, but for the purpose of checking the real or psychological effect of the laser, the laser is switched off and without wavelength.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Babak Vahdatpour
Street address
Sanbalistan Street, Ibn Sina Street, Shahada Square
City
Esfahan
Province
Isfehan
Postal code
81486-53141
Phone
+98 31 3112 2020
Email
vahdatpour@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ghalamreza Asgari
Street address
Hazarjarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Sanbalistan Street, Ibn Sina Street, Shahada Square
City
Esfahan
Province
Isfehan
Postal code
81486-53141
Phone
+98 31 3112 2020
Fax
Email
vahdatpour@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Sanbalistan Street, Ibn Sina Street, Shahada Square
City
Esfahan
Province
Isfehan
Postal code
81486-53141
Phone
+98 31 3112 2020
Email
vahdatpour@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amin Mokhtari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Sanbalistan Street, Ibn Sina Street, Shahada Square
City
Esfahan
Province
Isfehan
Postal code
81486-53141
Phone
+98 910 497 1330
Email
aminmokhtari111273@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available